The transport and storage of biological material operational indications and main pre-analytical errors that affect the validity of laboratory results
Article Sidebar
Main Article Content
Abstract
INTRODUCTION.
The transport and storage of biological material represent critical phases of the entire analytical process, which must ensure the stability of the samples to be analyzed in the laboratory.
AIM
The aim of this paper is to describe the state of the art in relation to the problems of the transport and storage of biological samples. In particular, the handling, packaging and transport procedures will be described in order to protect the health and safety of the staff involved in these operations and not to modify the diagnostic properties of the samples.
MATERIALS AND METHODS
The transport chain begins with the packaging and ends with the delivery of the material to the recipient. The correct necessary procedures that preserve the biological sample and the reliability of laboratory results will be described.
RESULTS
The critical steps that may affect the stability of the biological material will be underlined, paying attention to the pre-analytical variable "temperature and storage time". In addition, the tools that can be used for monitoring the above parameters will be evaluated.
CONCLUSION.
Incorrect storage temperatures, delays in transport, inadequate containers and / or packaging lead to an increase in the classic errors of the pre-analytical phase such as hemolysis of the sample, or overestimation / underestimation due to the instability of the analytes. The storage of the products during the transfer from one operating site to another one requires, at any stage, the application of rigorous procedures. It is very important to know the rules and recommendations to follow in order to standardize specific procedures useful to avoid possible pre-analytical errors that could affect the quality of the analytical data.
Downloads
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
References
Napolitano G, Farci Santarcangeli D, Fierro A. (2019). Il prelievo venoso: i principali errori preanalitici che influiscono sulla validità dei risultati di laboratorio. 10.30459/2019-9.
RIMeL - IJLaM, Vol. 2, N. 3-S1, 2006 pag 70 (MAF Servizi srl ed.)
WHO/CDS/CSR/LYO/2005.22 Guidance on regulations for the Transport of Infectious Substances.
http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_2005_22r%20.pdf (ultimo accesso: aprile 2020).
ISO 15189. Medical laboratories – Particular Requirements for Quality and Competence: Geneva, 2012.
Circolare n. 3, 8-5-2003 (Ministero Salute) Raccomandazioni per la sicurezza del trasporto di materiali infettivi e di campioni diagnostici.
http://www.salute.gov.it/imgs/C_17_normativa_394_allegato.pd (ultimo accesso: aprile 2020).
IATA. Packing Instruction 650 - biological Substances category B. www.iata.org/whatwedo/cargo/dgr/Documents/ (ultimo accesso: April 2020).
UN 3373 Packaging Requirements for Biological and Infectious Substances. www.un3373.com/info/regulations. (ultimo accesso: aprile 2020)
Zaninotto M., Brando B. et al. Raccomandazioni FISMeLab per il trasporto del materiale biologico
Fizzano M., Giovinazzo R. (2014). Spedire in sicurezza materiale diagnostico ed infettivo: lo stato dell’arte. Rivista degli infortuni e delle malattie professionali.
Miconi, Valentino & Brando, Bruno & Clerici, Pierangelo & Crivelli, Filippo & Curcio, Francesco & Giardini, Roberto & Magliano, Enrico & Ottomano, Cosimo & Stioui, Sabine & Torresani, Erminio & Zaninotto, Martina & Cenci, Anna Maria. (2019). Raccomandazioni della Federazione Italiana delle Società di Medicina di Laboratorio (FISMeLab) per il trasporto del materiale biologico. La Rivista Italiana della Medicina di Laboratorio. 15. 10.23736/S1825-859X.19.00007-0.
Clinical Laboratory Standard Institute (CLSI). Collection, transport, and processing of blood specimens for testing plasma-based coagulation assays and molecular hemostasis assays; approved guideline, 5th ed. CLSI document H21-A5. CLSI: Wayne, PA, 2008.
Clinical Laboratory Standard Institute (CLSI). Procedures for handling and processing of blood specimens for common laboratory tests; approved guideline, 4th ed. CLSI document H18-A4. CLSI: Wayne, PA, 2010.
Clinical Laboratory Standard Institute (CLSI). Urinanalysis; approved guideline, 3th. CLSI document GP16-A3. CLSI: Wayne, PA, 2009.
Clinical Laboratory Standard Institute (CLSI). Quality Control of Microbiological Transport Systems; approved standard, 2th. CLSI document M40-A2. CLSI: Wayne, PA 2014.
Vaught JB, Henderson MK. Biological sample collection, processing, storage and information management. Cancer Epidemiol Biomerkers Prev. 2006; 15:1582-4.
Buoro S., Mecca T. e at. (2016). Assessment of blood sample stability for complete blood count using the Sysmex XN-9000 and Mindray BC-6800 analyzers. Revista Brasileira de Hematologia e Hemoterapia. 38. 10.1016/j.bjhh.2016.05.010
Salvagno GL, Lippi G, Montagnana M, et al. Influence of temperature and time before centrifugation of specimens for routine coagulation testing. Int Jnl Lab Hem 2009;31: 462-7.
Zurcher M, Sulzer I, Barizzi G, et al. Stability of coagulation assays performed in plasma from citrated whole plasma transported at ambient temperature. Thromb Haemost 2008; 99:416-26.
Zaninotto M, Padoan A, Tasinato A, et al. An integrated system for monitoring the quality of sample transportation, Clin Biochem 2012;45: 688-90.
Plebani M. Charting the course of medical laboratories in a changing environment. Clin Chim Acta 2002;319: 87-100.
Laposata ME, Laposata M, Van Cott EM, Buchner DS, Kashalo MS, Dighe AS. Physician survey of a laboratory medicine interpretive service and evaluation of the influence of interpretations on laboratory test ordering. Arch Pathol Lab Med 2004; 128:1424-7.
Westgard JO, Darcy T. The truth about quality: medical usefulness and analytical reliability of laboratory tests. Clin Chim Acta 2004; 346:3-11.
Plebani M. The future of clinical laboratories: more testing or knowledge services? Clin Chem Lab Med 2005;43: 893-6. 8. Guidi GC, Lippi G, Solero GP, Poli G, Plebani M. Managing transferability of laboratory data. Clin Chim Acta 2006; 374:57-62.
Regan M, Forsman R. The impact of the laboratory on disease management. Dis Manag 2006; 9:122-30.
Martina Zaninotto, Adriano Tasinato, Gianni Vecchiato, Angelo Legnaro, Alessio Pinato, Mario Plebani. Performance specifications in extra-analytical phase of laboratory testing:Sample handing and trasportation. CB 50 2017 (574-578)
RIFERIMENTI LEGISLATIVI
• MINISTERO DELLE INFRASTRUTTURE E DEI TRASPORTI, DECRETO 21 GENNAIO 2013: Recepimento della direttiva 2012/45/UE della Commissione del 3 dicembre 2012 che adegua per la seconda volta al progresso scientifico e tecnico gli allegati della direttiva 2008/68/CE del Parlamento europeo e del Consiglio relativa al trasporto interno di merci pericolose (GU n. 61 del 13 marzo 2013).
• CIRCOLARE DEL MINISTERO DELLA SALUTE N. 3 DELL’8 MAGGIO 2003: Raccomandazioni per la sicurezza del trasporto di materiali infettivi e campioni diagnostici (http://www.salute.gov.it/imgs/C_17_normativa_394_allegato.pdf )
• MINISTERO DELLA SALUTE, DECRETO 2 novembre 2015: Disposizioni relative ai requisiti di qualita' e sicurezza del sangue e degli emocomponenti. (15A09709) (GU Serie Generale n.300 del 28-12-2015 - Suppl. Ordinario n. 69)
• MINISTERO DELLA SALUTE, Decreto 9 giugno 2015: Linee Guida Tracciabilità, Raccolta, Trasporto, Conservazione e Archiviazione di cellule e tessuti per indagini diagnostiche di ANATOMIA PATOLOGICA
(http://www.salute.gov.it/imgs/C_17_pubblicazioni_2369_allegato.pdf)